TRIAMINIC MULTI-SYMPTOM FEVER AND COLD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]

TRIAMINIC MULTI-SYMPTOM FEVER AND COLD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]
PDF | XML

NDC 0067-8116-04
Set ID 4e1a8f72-0ff6-4a0e-82ab-e97200ca6f28
Category HUMAN OTC DRUG LABEL
Packager GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Active ingredients (in each 5 mL)

    Acetaminophen 160 mg
    Chlorpheniramine maleate 1 mg
    Dextromethorphan HBr 5 mg
    Phenylephrine HCl 2.5 mg

  • Purposes

    Pain reliever/fever reducer
    Antihistamine
    Cough suppressant
    Nasal decongestant

  • Uses

    temporarily relieves
    minor aches and pains
    headache
    minor sore throat pain
    runny nose
    itchy nose or throat
    sneezing
    itchy, watery eyes due to hay fever
    nasal and sinus congestion
    cough due to minor throat and bronchial irritation as may occur with a cold
    temporarily reduces fever
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

    more than 5 doses in 24 hours, which is the maximum daily amount
    with other drugs containing acetaminophen

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    skin reddening
    blisters
    rash

    If a skin reaction occurs, stop use and seek medical help right away.

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    Do not use

    in a child under 4 years of age
    if your child is allergic to acetaminophen
    with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
    for the purpose of making your child sleepy

    Ask a doctor before use if the child has

    liver disease
    heart disease
    high blood pressure
    thyroid disease
    diabetes
    glaucoma
    a breathing problem such as chronic bronchitis
    cough that occurs with too much phlegm (mucus)
    chronic cough that lasts, such as occurs with asthma

    Ask a doctor or pharmacist before use if the child is

    taking

    sedatives or tranquilizers
    the blood thinning drug warfarin

    When using this product

    do not exceed recommended dosage
    marked drowsiness may occur
    sedatives and tranquilizers may increase drowsiness
    excitability may occur, especially in children

    Stop use and ask a doctor if

    nervousness, dizziness, or sleeplessness occur
    pain, nasal congestion or cough gets worse or lasts more than 5 days
    fever gets worse or lasts more than 3 days
    redness or swelling is present
    new symptoms occur
    cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical even if you do not notice any signs or symptoms.

  • Directions

    this product does not contain directions or complete warnings for adult use
    do not give more than directed
    shake well before use
    may be given every 4 hours, while symptoms persist. Do not give more than 5 doses in 24 hours unless directed by a doctor.
    use enclosed dosing cup only. Keep for use with this product. Do not use any other dosing device.

    Age

    Dose

    children under 4 years of age

    do not use

    children 4 to under 6 years of age

    do not use unless directed by a doctor

    children 6 to under 12 years of age

    10 mL

  • Other information

    each 5 mL contains: sodium 3 mg
    contains no aspirin
    store at controlled room temperature 20-25°C (68-77°F). Protect from light.
    close cap tightly
  • Inactive ingredients

    anhydrous citric acid, calcium sulfate, carrageenan, D&C red #33, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, tribasic sodium phosphate, xanthan gum

  • Questions or comments?

    call 1-800-452-0051

  • Principal Display Panel

    NDC 0067-8116-04

    Children’s

    Triaminic®

    Suspension

    Multi-Symptom

    Fever & Cold

    Acetaminophen (Pain Reliever/Fever Reliever)

    Chlorpheniramine maleate (Anithistamine)

    Dextromethorphen HBr (Cough Suppressant)

    Phenylephrine HCl (Nasal Congestant)

    Ages 6-11 Years

    Cold & Flu Symptom Relief
    Fever
    Runny & Stuffy Nose
    Aches & Pains
    Sore Throat
    Cough

    Grape FLAVOR

    4 FL OZ (118 mL)

    Child-Resistant Safety Cap.

    Do not use if printed neckband is broken or missing.

    What You Need to Help Make Your Child Feel Better

    PARENTS:

    Learn about teen medicine abuse

    www.StopMedicineAbuse.org

    The Triaminic® brand provides a broad range of products, created with the needs of children in mind.

    Trusted by Parents for over 50 years

    For more information plus helpful tips visit www.triaminic.com or call The Triaminic Clinic®.

    1-800-KIDS-987.

    Distr. By: GSK Consumer Healthcare, Warren, NJ 07059

    ©2016 GSK or its licensor.

    12680

    Childrens Triaminic Suspension Multisymptom Fever Cold 4 fl oz (118 mL) carton
  • INGREDIENTS AND APPEARANCE
    TRIAMINIC  MULTI-SYMPTOM FEVER AND COLD
    acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8116
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE1 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CALCIUM SULFATE, UNSPECIFIED FORM (UNII: WAT0DDB505)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-8116-041 in 1 CARTON09/30/2013
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/30/2013
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)